Remimazolam and Propofol on the Left Ventricular Strain During Anesthesia Induction for Non-cardiac Surgery
The Impact of Remimazolam and Propofol on the Left Ventricular Systolic Performance During Anesthesia-induction for Non-cardiac Surgery: a Speckle Tracking Analysis of the Left Ventricular Strain Using Transthoracic Echocardiography
1 other identifier
interventional
40
1 country
1
Brief Summary
This study to compare the impacts of remimazolam or propofol on the left ventricular global longitudinal strain (LV-GLS) during anesthesia induction for non-cardiac surgery. LV-GLS is analyzed by using speckle tracking technique of transthoracic echocardiography.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2023
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2021
CompletedFirst Posted
Study publicly available on registry
June 9, 2022
CompletedStudy Start
First participant enrolled
January 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedOctober 10, 2023
October 1, 2023
11 months
August 31, 2021
October 5, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
the averaged longitudinal strain of the left ventricle (%)
inter-group comparisons of the lowest values of the longitudinal strains of the left ventricle in the transthoracic echocardiography after administering remimazolam- or propofol-administration for anesthesia induction
2.5 minutes
Secondary Outcomes (4)
the longitudinal strain of the left ventricle in apical long-axis view (%)
2.5 minutes
the longitudinal strain of the left ventricle in apical 2 chamber view (%)
2.5 minutes
the longitudinal strain of the left ventricle in apical 4 chamber view (%)
2.5 minutes
the election fraction of the left ventricle
2.5 minutes
Study Arms (2)
Remimazolam
EXPERIMENTALremimazolam infusion
Propofol
ACTIVE COMPARATORpropofol infusion
Interventions
Remimazolam infusion for anesthesia induction
Eligibility Criteria
You may qualify if:
- left ventricular ejection fraction\> 50%
- no left ventricular regional wall motion abnormality
You may not qualify if:
- atrial fibrillation
- unfavorable airway
- hypotension requiring inotropic support
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Konkuk University Medical Center
Seoul, 05030, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tae-Yop Kim, MD, PhD
Konkuk University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Department of Anesthesiology
Study Record Dates
First Submitted
August 31, 2021
First Posted
June 9, 2022
Study Start
January 26, 2023
Primary Completion
January 1, 2024
Study Completion
January 1, 2024
Last Updated
October 10, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share